LYMPHOMAS

The B-Cell Lymphoma Moon Shot Program at The University of Texas MD Anderson Cancer Center wants to increase the cure rate of the disease from 30% to 60% within 5 years. In a presentation at the <em>22nd Annual</em> International Congress on Hematologic Malignancies, Michael Wang, MD, detailed results from 3 clinical trials that may help make that 5-year goal into a reality for patients with mantle cell lymphoma.

A novel bromodomain and extra terminal protein inhibitor demonstrated promising early activity and a manageable safety profile in the treatment of patients with relapsed or refractory lymphoma in the results of a first-in-human phase I trial.

The field of mantle cell lymphoma underwent a significant change with the FDA approval of ibrutinib in 2013. Now, the recent approval of&nbsp;acalabrutinib has similarly impacted the treatment landscape, as experts say it could be associated with slightly fewer adverse events than ibrutinib, according to Andre Goy, MD.

There was a 16-week complete response rate of 42% per CT imaging with the combination of venetoclax (Venclexta) and ibrutinib (Imbruvica) in patients with previously untreated or relapsed/refractory mantle cell lymphoma, according to results from the phase II AIM study.

According to results from an extended follow-up of the CheckMate-205 trial looking at patients with relapsed/refractory classical Hodgkin lymphoma after autologous hematopoietic cell transplantation,&nbsp;nivolumab (Opdivo) caused an overall objective response rate of 69%.

Several new indications were approved by the FDA in March, including blinatumomab (Blincyto)&nbsp;for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here&rsquo;s a look back on the FDA happenings for the month of March 2018.

Based on findings from the phase III ECHELON-1 trial,&nbsp;brentuximab vedotin (Adcetris) has been approved by the FDA for use in&nbsp;combination with chemotherapy as a frontline treatment for adult patients with stage III or IV classical Hodgkin lymphoma,&nbsp;according to a statement from Seattle Genetics, the manufacturer of the CD30-targeted antibody-drug conjugate.

Responses to lisocabtagene maraleucel have been potent and durable in the&nbsp;treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.&nbsp;Separate exploratory&nbsp;analyses of this population treated with liso-cel found that high tumor burden and a series of in ammatory biomarkers were associated with high chimeric antigen receptor T-cell expansion and higher rates of cytokine release syndrome and neurotoxicity.

Tazemetostat showed efficacy in heavily treated patients with relapsed/refractory non-Hodgkin lymphoma in interim results from a phase II trial. Investigators hope that the analysis of a 62-gene panel biomarker performed on the same patient population will help to identify the patients who will have an even stronger response to the oral EZH2 inhibitor developed by Epizyme.

One of the most exciting advancements in the lymphoma community has been the FDA approval of axicabtagene ciloleucel (axi-cel; Yescarta) for patients with non-Hodgkin lymphoma&nbsp;in October 2017.

According to phase I findings published in <em>The Lancet Oncology,</em>&nbsp;an&nbsp;objective response rate of 37% was induced in patients with&nbsp;relapsed/refractory lymphoma or chronic lymphocytic leukemia treated with the&nbsp;PI3K-delta inhibitor umbralisib.

Treatment with the&nbsp;CD19-targeted chimeric antigen receptor T-cell therapy lisocabtagene maraleucel (liso-cel, formally known as JCAR017) demonstrated&nbsp;a complete response rate of 63% and an&nbsp;objective response rate of 81%&nbsp;in patients with&nbsp;relapsed/refractory diffuse large B-cell lymphoma.

Brian T. Hill, MD, PhD,&nbsp;shares more insight on acalabrutinib and ibrutinib&rsquo;s efficacy in patients with MCL and highlights emerging novel strategies in the treatment landscape.

Lymphoma expert Andrew M. Evens, DO, MSc, FACP, has joined Rutgers Cancer Institute of New Jersey as associate director. He is also serving as medical director of the oncology service line at RWJBarnabas Health. Evens will focus on integrated cancer care delivery in his roles across both institutions.

Peter Martin, MD, discusses a phase I, open-label, multicenter trial of oral azacitidine (Vidaza) plus R-CHOP in people with high-risk, previously untreated DLBCL, grade 3B follicular lymphoma, or transformed lymphoma.

Based on results of the phase II JULIET study,&nbsp;a supplemental biologics license application for the CAR T-cell therapy tisagenlecleucel (Kymriah) has been granted a priority review by the FDA&nbsp;as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma who are ineligible for or relapse after autologous stem cell transplant.

Based on findings from the phase III ECHELON-1 trial, a&nbsp;supplemental biologics application (sBLA) for&nbsp;brentuximab vedotin (Adcetris)&nbsp;in combination with Adriamycin, vinblastine, and dacarbazine (AVD) has been granted a priority review by the FDA for the frontline treatment of&nbsp;advanced classical Hodgkin lymphoma, according to a statement from the company developing the CD30-targeted antibody-drug conjugate, Seattle Genetics.

The combination of brentuximab vedotin (Adcetris) and nivolumab (Opdivo) demonstrated promising clinical activity in patients with&nbsp;relapsed/refractory Hodgkin lymphoma,&nbsp;according to results from a phase I/II trial presented at the 2017 ASH Annual Meeting.

Treatment with the novel PD-1 inhibitor cemiplimab induced responses in half of the patients with&nbsp;Hodgkin lymphoma in a phase I study of patients with B-lymphoid malignancies; among patients with&nbsp;B-cell non-Hodgkin lymphoma treated with the monotherapy, the overall response rate was 11.1%, according to a poster presentation at the 2017 ASH Annual Meeting.&nbsp;

Treatment with&nbsp;tisagenlecleucel (Kymriah) continues to excite the possibilities seen with chimeric antigen receptor T-cell therapy with impressive responses seen with the therapy in patients with&nbsp;relapsed/refractory diffuse large B-cell lymphoma. In the phase II JULIET trial, an overall response rate of 53.1%&nbsp;was observed, according to findings presented at the ASH Annual Meeting.&nbsp;

Pembrolizumab (Keytruda) has received a priority review from the FDA for a supplemental biologics license application (sBLA) for the treatment of&nbsp;adult and pediatric patients with relapsed/refractory primary mediastinal large B-cell lymphoma (PMBCL), according to a press release from Merck,&nbsp;the manufacturer of pembrolizumab. The findings were first presented at the 14th International Conference on Malignant Lymphoma and updated data were recently presented at the 2017 ASH Annual Meeting.

Updated results from the TRANSCEND study demonstrated that&nbsp;liso-cel (lisocabtagene maraleucel), formally known as JCAR017, induced an 81% objective response rate and a 63% complete remission rate in patients with relapsed/refractory diffuse large B-cell lymphoma.

The addition of brentuximab vedotin (Adcetris) to doxorubicin, vinblastine, and dacarbazine (A+AVD) reduced the risk of progression and death by 23% in patients with advanced-stage Hodgkin lymphoma (HL) compared with standard&nbsp;ABVD (doxorubicin [Adriamycin], bleomycin, vinblastine, and dacarbazine) chemotherapy, according to results of the phase III ECHELON-1 clinical trial.&nbsp;

Treatment with the chimeric antigen receptor T-cell therapy axi-cel&nbsp;(axicabtagene ciloleucel; Yescarta) demonstrated improvement in long-term survival rates in patients with refractor, aggressive non-Hodgkin lymphoma,&nbsp;according to updated findings from the pivotal ZUMA-1 trial.

Mogamulizumab improved progression-free survival in previously treated patients with cutaneous T-cell lymphoma by 4.6 months compared with vorinostat (Zolinza),&nbsp;according to findings from the phase III MAVORIC study.